Usha Sharma – Mumbai
The Central Drugs Standard Control Organization (CDSCO) has released a draft version of guidelines on recall and rapid alert system for drugs including biologics and vaccines. It has called for suggestions or objections from the industry stakeholders to submit responses before November 7, 2012.
Dr GN Singh, Drug Controller General of India (DCGI) said, “Our mission and vision is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical device. To comply with this, we will address these aspects before enforcing into an act. We have published draft guidelines on October 22, 2012 and asked the stakeholders to revert back before November 7, 2012. Once we will get responses, we will review them accordingly. The suggestions or objections, if found to be in public interest will be forwarded to the Ministry of Health.”
“The review process will take 45 days and then will be sent to the Health Ministry and then to the Law Ministry. Overall, we are expecting that it will take three to four months to become an act,” Singh added.
A rapid alert system is to transmit only those ale